(104 days)
For use in the endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where total obstructions cannot be crossed with standard guide wires.
Spectranetics laser atherectorny catheters consist of a bundle of optical fibers, encased within medical grade tubing. The optical fibers conduct ultraviolet laser light (excimer laser light at 308 nm) from a source to the tip of the catheter. The catheter is inserted into a patient's vasculature along the length of a previously inserted medical guidewire, allowing the attending physician to deliver laser energy targeted to a lesion (blockage) in the blood vessel. Both over-the-wire and rapid-exchange catheter configurations are available. Laser energy impinged on a blockage ablates, or debulks, the lesion material thus opening the vessel, permitting placement of devices used in vascular interventions.
Spectranetics laser catheters are supplied in several models having tip diameters between 0.9 mm and 2.5 mm, appropriate for interventional use in peripheral arteries. Both over-the-wire and rapid exchange models are available.
Here's a breakdown of the acceptance criteria and study information for the Spectranetics CLiRpath Excimer Laser Catheter, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a dedicated table or section. However, it implicitly defines success metrics that can be interpreted as performance targets.
| Performance Metric | Reported Device Performance | Acceptance Criteria (Implicit) |
|---|---|---|
| Successful crossing of lesions | 79% | High success rate for crossing totally occlusive peripheral vascular disease that cannot be crossed with standard guide wires. |
| Overall procedural success | 72% | High overall success in the procedure, addressing symptomatic infrainguinal lower extremity vascular disease. |
| Re-establishment of straight-line blood flow to the foot | 79% | High success rate in restoring distal blood flow for limb preservation. |
| Serious adverse events | "more rare than those observed during a larger registry study of laser atherectomy in the arteries of the legs." | Low incidence of serious adverse events, comparable to or better than established procedures. |
| Biocompatibility | Confirmed in accord with ISO 10993 series | Met ISO 10993 standards. |
| Sterilization | Validated in accord with ISO 11135 | Met ISO 11135 standards. |
| Package integrity | Initially validated, 100% visually verified | Maintained integrity. |
| Device integrity and functionality | Met or exceeded Spectranetics in-house requirements and ISO 10555-1 | Met internal and external standards for catheter performance. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set: 47 patients.
- Data Provenance: Retrospective or Prospective: The study is described as "patients were enrolled at investigational sites," which usually implies a prospective clinical study.
- Country of Origin: United States, Germany, and Belgium.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not provide information on the number of experts or their qualifications for establishing ground truth within the clinical study. The "ground truth" for the clinical success metrics (lesion crossing, procedural success, blood flow re-establishment) would have been determined by the treating physicians and potentially confirmed by diagnostic imaging and patient outcomes.
4. Adjudication Method for the Test Set:
The document does not describe a specific adjudication method (e.g., 2+1, 3+1, none) for the clinical study's outcomes. Clinical outcomes are typically assessed by the treating physician and may be reviewed by an independent clinical events committee or core lab, but this detail is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a clinical trial focused on the device's performance in patients, not on comparing human reader performance with and without AI assistance. The CLiRpath is a medical device (laser catheter), not an AI-powered diagnostic tool.
6. Standalone Performance Study:
Yes, a standalone performance study (algorithm only without human-in-the-loop performance) was effectively done. The clinical study evaluated the CLiRpath catheter's performance in isolation as a treatment device, with human operators (physicians) using the device, but not as part of an AI system providing diagnostic or treatment recommendations. The reported metrics (lesion crossing, procedural success, blood flow re-establishment) are direct measurements of the physical device's capabilities when operated by a clinician.
7. Type of Ground Truth Used:
The ground truth for the clinical study was based on:
- Clinical Outcomes Data: Successful crossing of lesions, overall procedural success, and re-establishment of straight-line blood flow to the foot are direct clinical outcomes observed and measured during the procedure and potentially post-procedure.
- Adverse Event Data: Tracking of serious adverse events.
8. Sample Size for the Training Set:
The document does not mention a distinct "training set" for the clinical evaluation. The 47 patients constitute the test set for the performance evaluation of the device in a clinical setting. This is a medical device, not an AI model, so the concept of a "training set" for an algorithm is not applicable in this context.
9. How the Ground Truth for the Training Set Was Established:
As there is no "training set" in the context of an AI algorithm, this question is not applicable to the CLiRpath device's evaluation as described. The "training" for such a device would be the extensive bench testing, qualification, and validation studies (mentioned under "BIOCOMPATIBILITY, STERILIZATION, PACKAGING, AND BENCH TESTING"), which established its adherence to manufacturing and design specifications.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).